QMS - Executive

Alkem Laboratories Ltd.; Daman; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Alkem Laboratories Ltd. in Dadra and Nagar Haveli and Daman and Diu is seeking a Quality Management System professional to manage and maintain site QMS procedures and ensure timely closure of deviations, incidents, CAPAs, and change controls.

The role involves trend analysis, CAPA verification, and coordinating documentation and regulatory compliance. The candidate will conduct QMS training, support investigations, and ensure GDP compliance while maintaining electronic records and facilitating

Qualifications

• Experience in managing Quality Management System documentation and processes.

Responsibilities

• Manage and maintain site Quality Management System procedures.
• Ensure timely processing and closure of Deviations, Incidents, investigations, CAPAs, Change Controls, and Risk Assessments.
• Review trend analysis of quality events and identify improvement opportunities.
• Track CAPA implementation and effectiveness verification.
• Ensure timely closure of corrective and preventive actions.
• Conduct periodic CAPA review meetings with stakeholders.
• Review and coordinate change control proposals.
• Assess quality and regulatory impact of proposed changes.
• Monitor implementation and closure timelines.
• Review SOPs, protocols, reports, and quality documents.
• Ensure compliance with GDP (Good Documentation Practices).
• Maintain QMS records in electronic systems.
• Conduct QMS awareness and GMP training programs.
• Support employees in understanding quality systems requirements.
• Facilitate investigation of deviations, incidents, Market complaints, OOS, and OOT cases.
• Ensure root cause analysis using appropriate tools.
• Support closure and effectiveness verification of action plans.

Skills

QMS Management

CAPA Governance

Change Control Management

Documentation & Compliance

Training & Awareness

Investigation Management

Job description

• Manage and maintain site Quality Management System procedures.
• Ensure timely processing and closure of Deviations, Incidents, investigations, CAPAs, Change Controls, and Risk Assessments.
• Review trend analysis of quality events and identify improvement opportunities.

QMS Management

• Manage and maintain site Quality Management System procedures.
• Ensure timely processing and closure of Deviations, Incidents, investigations, CAPAs, Change Controls, and Risk Assessments.
• Review trend analysis of quality events and identify improvement opportunities.

CAPA Governance

• Track CAPA implementation and effectiveness verification.
• Ensure timely closure of corrective and preventive actions.
• Conduct periodic CAPA review meetings with stakeholders.

Change Control Management

• Review and coordinate change control proposals.
• Assess quality and regulatory impact of proposed changes.
• Monitor implementation and closure timelines.

Documentation & Compliance

• Review SOPs, protocols, reports, and quality documents.
• Ensure compliance with GDP (Good Documentation Practices).
• Maintain QMS records in electronic systems.

Training & Awareness

• Conduct QMS awareness and GMP training programs.
• Support employees in understanding quality systems requirements

Investigation Management

• Facilitate investigation of deviations, incidents, Market complaints, OOS, and OOT cases.
• Ensure root cause analysis using appropriate tools.
• Support closure and effectiveness verification of action plans.